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BioLineRX Ltd (NASDAQ:BLRX)

Q1 2014 Earnings Conference Call

May 20, 2014 10:00 AM ET

Executives

Joshua Drumm – Senior Vice President-Investor Relations, Tiberend Strategic Advisors, Inc.

Philip A. Serlin – Chief Financial Officer and Chief Operating Officer

Kinneret Livnat Savitsky – Chief Executive Officer

Analysts

Bert C. Hazlett – Ladenburg Thalmann & Co., Inc.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2014 Conference Call. All participants are present in listen-only mode. Following the managements formal presentation, instructions will be given for the question-and-answer session. (Operator Instructions) I would now like to turn the call over to Josh Drumm of Tiberend Strategic Advisors to read the Safe Harbor statement. Josh, please go ahead.

Joshua Drumm

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call other than historical facts are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements.

These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLine’s business, financial condition and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in BioLineRX’s annual report on Form 20-F, quarterly reports that we filed in a 6-K and other reports filed by BioLineRX with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements.

At this time, it is my pleasure to turn the call over to Mr. Phil Serlin, Chief Financial and Operating Officer of BioLineRx. Phil, please go ahead.

Philip A. Serlin

Thank you, Josh. And thank you all for joining us this morning. Before I begin, I just want to point out that part of our call this morning will be accompanied by a brief slide presentation. We filed the presentation about 15 minutes ago, so you can find on the EDGAR website or in the SEC filings listed in the investors section of our website www.biolinerx.com.

Before we address the slide presentation Dr. Kinneret Savitsky, our CEO and I would like to make some general statements regarding our recent progress and discuss our overall strategies for advancing our clinical pipeline. We anticipate this call to be relatively brief, as we have multiple active clinical and pre-clinical programs ongoing with anticipated milestones concentrated in the second half of this year and early next year. This quarter we were focused primarily on advancing our pipeline, particularly on progressing our lead clinical program in oncology and immunology which Kinneret will discuss in greater detail.

As we discussed last quarter, we believe our current pipeline has reached a critical mass, and our intention is to focus on moving our most advanced programs forward as efficiently and expeditiously as possible. In March, we completed an equity financing of $24.1 million that further secured our cash position. Our strong cash position now $37.5 million as of March 31, 2014, allows us to follow through on our current and planned clinical activities through 2016.

We are very happy to have the financial flexibility to execute on this more focused, more aggressive clinical strategy which we believe will result in BioLine achieving several potentially transformative milestones in the next quarters. We expect potential success in these high value and orphan drug opportunities to translate into significant partnership interest and added value for our shareholders. While our primary strategic focus is on clinical research and development, we will continue to leverage our deep expertise and extensive academic network to identify promising therapeutic opportunities.

Our strength in this area has been proven by our ability to advance handpicked early stage programs into the clinic. And we intend to continue to foster these relationships. There maybe additional opportunities to capitalize on our drug screening capabilities and we will be exploring this as an additional value driver for BioLine.

In addition, we’ve continued to seek and secure collaborative and licensing partnerships for our pipeline assets and these efforts will remain at the forefront in parallel with our R&D efforts.

With that, I will hand the call over to Kinneret, who will provide a brief overview of our upcoming milestones for our lead clinical programs. And then move into the slide presentation for some additional detail on these and other select programs from our pipeline.

Kinneret Livnat Savitsky

Thanks, Phil, and good morning everyone. As we mentioned we have a great deal of clinical activity ongoing at the moment with several upcoming milestones that I’d like to review for you now.

BL-8040 is our most advanced and robust in-house clinical program, which we see as an oncology platform for hematological indications. It is currently being evaluated in three different oncology indications two at BioLine in AML, acute myeloid leukemia and stem cell mobilization as well as an investigator-initiated phase 1/2 study in CML or chronic myeloid leukemia, which we announced following our year-end conference call for 2013.

We have received orphan drug status from the FDA for both the AML and stem cell mobilization indication. We anticipate reporting final data from our ongoing Phase 2 study in AML in early 2015 which follows the positive partial data we reported from this study at the end of last year. We also expect to enter the clinic with BL-8040 for stem cell mobilization in the next few months which results in the second half of 2014 and anticipate initiation of the investigator-led phase 1/2 study in CML later this year.

Our unique program for celiac disease BL-7010 is also progressing according to plan. In March we reported positive safety and tolerability results from the single administration dose escalation part of our Phase 1/2 study. And we are currently completing the repeated dose stage for which we expect to report results mid 2014. Upon similar favorable results, we would expect to move forward with randomized controlled efficacy study before the end of 2014.

We expect this clinical milestone to be the primary value drivers for BioLine over the next six to eight months, which is why we have chosen to focus the majority of our resources on executing on them successfully. As you can see there are several significant value inflection points anticipated for 2014 and beyond and we look forward to sharing our progress on these milestones over the following quarters.

I would like to turn your attention now to the slides accompanying this call for a more detailed walk through of our primary development programs. As you can see on Slide 3, we show our full pipeline, which currently consist of the lead program I just discussed as well as additional partnered and unpartnered development program at various stages. I will not go into further details on our non-lead programs on this call. But I will provide an update on our most advanced partnered programs BL-1040, which is in the midst of an ongoing pivotal CE Mark Registration study in the hands of our partner Bellerophon formerly called Ikaria.

Now let’s turn to Slide 5. To remind you this is a placebo-controlled study expected to enrolled approximately 300 patients. Patients will be followed for six months. Primary endpoints include end diastolic volume index, Quality-of-Life Questionnaire and the six-minute walk test. We were recently made aware by Bellerophon of an expected delay incompletion of the PRESERVATION I study, due to slower than expected patient enrollment. Based on this information, we are updating the anticipated timing for a study completion to mid 2015 based on what we have learned from Bellerophon.

Although there is a delay in the study, we are encouraged by the fact that over 200 patients have already been enrolled in the study out of the total expected enrollment of about 300 patients. This is a large and complex study being conducted at 80 sites in nine countries, including 14 sites in the U.S. Bellerophon has indicated to us that it expects to complete enrollment by the end of 2014, and as mentioned complete the study by mid 2015.

Bellerophon has also indicated to us that it expects to file for CE Mark in Europe in the second half of 2015. With regard to the above mentioned delay in the trial I would also like to mention that we have recently being engaged in discussion with Bellerophon relating to its performance under the BL-1040 licensing agreement.

These discussions as focused on what we believe to be breached of the agreement by Bellerophon as well as disagreements about the timing of a $12.5 million milestone payment that Bellerophon would owe to us in the future based upon progress in the BL-1040 clinical development program.

We have had a number of discussions with Bellerophon on these issues and these discussions are continuing. Although we hope we can resolve the outstanding issues with Bellerophon in a friendly way, if we are unable to reach agreement with Bellerophon on these issues, we would consider all other remedies available to us.

I am now turning to Slide 6, which discusses BL-8040, our CXCR4 antagonist for AML and other hematological indications. Based on preclinical studies and the partial results that we published in December 2013, we saw a very nice robust apoptosis and also significant mobilization activity of the cancer cells on the bone marrow to the circulation.

We also have a very strong IP portfolio covering BL-8040, we have 25 patents pending worldwide, 13 were already granted. And we also received from the FDA the orphan designation both from for AML and also for stem cell mobilization.

Regarding the AML program, it’s a Phase 2 study under an IND, we have eight sites altogether three in the U.S. and five in Israel. As I mentioned before in December 2013, we announced partial results from the dose escalation, at this stage we reached third cohort, so far there were no dose-limiting toxicity and we are still in this dose escalation phase. We will probably end this stage of the study around mid-2014 and we will move right away towards the extension phase and the results, the completion of the study is expected in early 2015.

Regarding the second, the second and the third study, so the stem cell mobilization study we did all the submissions, we will probably start the study in the next few months and the results are expected in H2 this year. And the CML study which is an investigator-initiated study phase 1/2 will be conducted in Tel-Hashomer by Prof. Nagler and we’ll probably start in the next few months.

Now turning to Slide 7, slide 7 is about BL-7010 that’s our product for celiac as I mentioned in our previous call we’re very excited about this program. We see a significant increase by potential partners we also noticed an unmet medical needs with only four clinical programs around the world.

And the only solution today for celiac patients is gluten-free diet and the big chunk of these patients although they are under gluten-free diet they are still symptomatic. We’re now running the phase 1/2 in celiac patients in Finland in a leading site there it consists of two phases the dose escalation in which we’ve several cohorts, for single administration which we finished in March. And we moved to the repeated administration 14 days of repeated administration and the result of this phase is expected in mid year. I just want to mention that in the single administration we didn’t have any toxicity or safety issues. We expect to start the next study which will be a randomized, controlled efficacy study towards the end of the year.

And now I’ll turn it over to Phil to give the financial overview.

Philip A. Serlin

Thank you, Kinneret. If you all turn to Slide 9, you can see that we completed a significant financing in early 2014, we raised $24.1 million in underwritten public offering at ADS’s. Roth Capital was the lead and Maxim with co-managers. Our financing included 1.2, almost 1.3 million ADS’s to cover an over-allotment option and it was significantly oversubscribed and we feel it was a very successful offering. This offering broadened our U.S. institutional base our ADS’s were purchased by high caliber institutions. And U.S. investors now hold roughly two-thirds of our outstanding shares. It also has put us in a strong cash position we have $37.5 million at March 31, 2014 this funds our operational capital through the end of 2016. And we also expect to reach several value inflection points during this period.

If you all turn to Slide 10, we will now review the expense categories. Research and Development first our total R&D expenses decreased by $2.8 million to a total of $2.7 million in Q1 2014 this results primarily from the termination of the BL-1020 CLARITY trial that we terminated in March 2013. And the decrease was partially offset by a ramp up in spending on a lead clinical stage development programs BL-8040 and BL-7010.

As far as sales and marketing is concerned S&M expenses increased by $0.2 million to $0.4 million in Q1 2014, and this increase resulted primarily from professional fees that were connected with increased business development activities. Our G&A expenses were very constant both between Q1 2013 and Q1 2014 and amounted to $1 million for both quarters.

If you turn to Slide 11. Our non-operating income decreased $1.8 million to $1.7 million in Q1 2014, and this primarily stems, this whole expense category primarily stems from fair value adjustments that related to our warrant liability on the balance sheet.

Financial income and expenses, net financial income was $0.3 million for Q1 2014, compared to net financial expenses of $0.4 million for Q1 2013 and these changes primarily result from changes in the average exchange rate of the NIS to the U.S. dollars since we have net assets in dollars.

The last slide which we always find to be very important shows our major milestones over the next 12 months. I am on slide 12. As you can see on the right side BL-8040, we are expecting to start a stem cell mobilization of phase 1 initiation in the next couple of months and that should be completed by the end of the year.

In addition, we expect by mid-year to have, if you look at the beige to have a partial results from the – ongoing phase 2 in AML for BL-8040. And we hope to complete that study towards the beginning of next year, as you can see the beige bar. In addition, we are expecting to start an investigator-initiated study in CML will be phase 1/2 and that should start also sometime in the middle of this year.

On the left side in purple you can see BL-7010 our Celiac Disease program. We expect to complete the phase 1/2 sometime by mid-year and we also expect to start a pivotal study for this program in efficacy study by the end of the year. BL-1040 as we mentioned that’s the program which is partnered with Bellerophon, we expect based on information that was given to us by Bellerophon to have the enrollment completed on this study, by the end of 2014 and we expect completion of the study to be in mid 2015. So those are our major milestones as I mentioned over the next 12 months. That concludes the formal part of our presentation.

We’d now like to open the call up for questions. Operator?

Question-and-Answer Session

Operator

Thank you. Ladies and gentlemen at this time we will begin the question-and-answer session. (Operator Instructions) Your first question is from [Saleem Kashif] (ph). Please go ahead.

Unidentified Analyst

Hi, good afternoon. I’m private investor and I invest in the company, but I’m so disappointed and frustrated because there is no correlation between your declaration and your presentation on what you are saying declaration and the reality. All the time you keep changing the dates and for all results of the [clinical phase] (ph) that are occurring. And I would like, as a private investor to know what you are doing to regain the trust of the private investors?

Kinneret Livnat Savitsky

Thank you Saleem for your question. And so let me just explain what are the timelines that changed and what are the timelines that we are spending in meeting our milestone. So first the delay in BL-1040 is something that is information that we received from our partner, Bellerophon, the minute we learned about the delay we made sure to let our investors to know about this delay. I have to say that this is a very complex study, it’s a 300 patient study, a severe patients that are hospitalized, it’s not easy to recruit these patients and it’s also hard to predict or forecast the recruitment especially since this study is in 80 sites. And its not only in our recruitment when you start with several sites still you reach stage where all the sites are open this is one issue, the second issue is that in some countries they received conditional approvals and therefore it’s hard to know exactly when you’ll get the green lights from the regulatory to continue recruiting the rest of the patients. So this is about BL-1040.

Regarding our AML program the BL-8040 we didn’t have any delay, we announced the partial results sometime by the end of 2013 with encouraging results regarding the end of the escalating stage. We’re still saying that the results will be in mid this year. I have to say that, its bit hard to give a very clear timeline since it’s hard to forecast exactly at what core – which those you’re going to stop and continue to the escalating stage of the study.

And therefore, it’s a bit hard to give a very clear timeline regarding the exact timing of when we’ll move to the next phase of the study. The same and also regarding to the celiac program, we mentioned that the final results will be in mid 2014, we are still saying that the top-line results will be at the same timing that we mentioned before. There is no change in the timeline, also we expect to start the next study, if everything will be according to plan and there will be no toxicity issues this year and nothing has changed from this angle as well.

Unidentified Analyst

Thank you.

Kinneret Livnat Savitsky

You’re welcome.

Unidentified Analyst

I have another question – may I ask another question.

Kinneret Livnat Savitsky

Yes, please.

Unidentified Analyst

Yes, I would like to ask about the BL-5010, you mentioned in your report that you are in advanced negotiations with pharmaceutical companies about partnership, in case that there is no (indiscernible) are going to develop the BL-50 alone?

Kinneret Livnat Savitsky

So this is something that could be changed in – based on the plans that we discussed in the previous calls that we had with investors. And this is because this discussions are advancing and we feel that the direction that our potential partners are taking the compound is into other indications. And therefore we feel that it will be wrong to start this seborrheic keratosis study as we planned. Although, we have all the approval from the German authorities and if something will change we will consider conducting the study as planned. The discussions are advancing as we expected I have to say on the one end and the other end we need to take into account that this discussions takes time and we expect still to reach an agreement hopefully in the next six months or so.

Unidentified Analyst

Thank you. I would like – and just last question for the Israeli private investors, are you going to make meeting with them because there is a lot of concerns, lot of questions and there is no answer for their questions, are you going to amplify their concerns by answering investor questions and one of the Israeli webcast?

Kinneret Livnat Savitsky

Yes, we do have several channels in Israel in order to be available for Israeli investors as well. Last week we were giving, we were participating in a panel in Tel Aviv from Oppenheimer. Last year we were in another forum that we gave a presentation called sponsor forum. So we do have several conferences and meetings with Israeli investors on a regular base as well.

Unidentified Analyst

Thank you a lot. And have a good day.

Kinneret Livnat Savitsky

Thank you.

Unidentified Analyst

Thank you a lot.

Operator

Your next question is from Bert Hazlett of Ladenburg. Please go ahead.

Bert C. Hazlett – Ladenburg Thalmann & Co., Inc.

Yes, good morning. My apologies I may have missed some of the commentary, but just regarding BL-8040. As you consider it more broadly as you gain experience with it in the clinic in AML and stem cell mobilization and maybe soon to be CML. Is your experience or instincts telling you to broaden the consideration of this molecule or they telling you to focus it more on let’s says specific indication like AML or stem cell mobilization. Do you have a sense of how you might handle it just given those two scenarios at this point?

Kinneret Livnat Savitsky

Thanks, Bert. Yes, we do feel that the right thing will be to broaden the indications that we are looking at for BL-8040 based on the data that we have so far, the fact that we know that the compound works as a standalone both from mobilization and also for apoptosis do give us positive or do show the potential of the compound in other indications as well. We need remember that we started with very difficult patients here these are reluctant and refractory patients. And we do feel that it will be right to try and look at the activity of the compounds in other indication. In the last ASH conference we showed some pre-clinical data in FLT3 mutations I think this is the one of the directions that you would like to consider, there are other indications that we are discussing internally just too early to talk about it, but once we’ll make our decision of course we will announce it.

Bert C. Hazlett – Ladenburg Thalmann & Co., Inc.

Terrific, and then again my apologies I may have missed it. But what are the options that you are considering with Bellerophon broadly, what can you do, what do you think you will do at this point and just kind of the roadmap for your options for the next several months?

Kinneret Livnat Savitsky

So unfortunately I cannot discuss this issue I just have to say that we’re talking to Bellerophon on a constant basis. We do see this study as an important study and we won’t jeopardize it. But I cannot disclose any more information.

Bert C. Hazlett – Ladenburg Thalmann & Co., Inc.

Okay, I figured a try. Thank you very much.

Kinneret Livnat Savitsky

You’re welcome.

Operator

(Operator Instructions) There are no further questions at this time. Before I ask Dr. Kinneret Savitsky to go ahead with her closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1866-276-1485. In Israel, please call, 039-255-945. Internationally, please call 9723-925-5945. Dr. Savitsky, would you like to make your concluding statement?

Kinneret Livnat Savitsky

Yes, thank you. I want to thank all of you for joining us today. We hope we have successfully highlighted the many significant catalyst, we have in the next 12 months or so. We are committed to executing our clinical strategy both for our internal program as well as with our partners. And we are very well funded to achieve our planned clinical milestones. Our primary goal is to demonstrate the clinical value of our lead compounds effectively in well designed human studies in order to drive favorable valuations for these programs among potential partners. We are well on our way in this regard and we look forward to updating the market on our continued progress. We thank you again for joining us today and for your support. Good bye.

Operator

Thank you. This concludes the BioLineRX first quarter 2014 conference call. Thank you for your participation. You may go ahead and disconnect.

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